The TGA has published outcomes of the consultation on proposed low0negligible risk changes to the Permissible Ingredients Determination, which occurred in August - September 2022.
The outcome of the consultation is largely aligned with CMA’s submission to the consultation, which advocated for a number of changes to reduce the level of impact of the proposal. These changes relate to warning statements for:
The final changes will commence on 1 March 2023, after which new (or newly ‘grouped’) medicines that are released for supply are generally expected to be compliant with new requirements.
For existing medicines, a one-year transition period will be instated to allow sponsors to ensure product compliance, ending on 1 March 2024.
Please read today’s Tech Alert for more information and details.